Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of k-321 eye drops after descemetorhexis in participants with fuchs endothelial corneal dystrophy (fecd)

Conditions: Fuchs Endothelial Corneal Dystrophy

Summary: a study to assess the safety and efficacy of k-321 in participants with fecd after descemetorhexis.


Eligibility criteria:
inclusion criteria: * is at least 18 years old at the screening visit (visit 1) * has a diagnosis of fecd at visit 1 * meets all other inclusion criteria outlined in clinical study protocol exclusion criteria: * is a female patient of childbearing potential and any of the following is true: 1. is pregnant or lactating/breastfeeding, or 2. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy) * has a study eye with a history of cataract surgery within 90 days of visit 1 * meet any other exclusion criteria outlined in clinical study protocol
bryophyllum pinnatum treatment of anxiety related to signs of preterm birth

Conditions: Preterm Labor; Anxiety

Summary: the present iit (investigator-initiated trial) study is a prospective, randomised, placebo-controlled, double blind trial. women hospitalised with signs of preterm birth can be recruited for the study. participants will take study medication for 2 weeks (or until birth) and fill out a questionnaire at 3 time points (at baseline, after 1 week and after 2 weeks) to assess state of anxiety and sleep quality. furthermore, information regarding adverse events and the further course of the pregnancy are recorded.

preterm birth is one of the leading causes for mortality and morbidity in newborns and preterm contractions are the cause of a considerable part of preterm deliveries. in the treatment of preterm labour, tocolytic medications are often used that are associated with numerous side effects for the pregnant woman, which limits their use in time. preparations from bryophyllum pinnatum, which demonstrated excellent tolerability, constitute a safe alternative for tocolytic treatment. it was introduced as an alternative tocolytic by anthroposophic medicine in europe and is used as a monotherapy or add-on therapy for preterm labour in many perinatal clinics in switzerland today. in vitro studies support the use of b. pinnatum as a tocolytic. in addition, there are also limited options for the treatment of mental disorders and sleep disturbances during pregnancy. anxiety plays a major role in the development of preterm labour and often leads to administration of tocolytics longer than necessary. preparations from b. pinnatum have traditionally been in the treatment of anxiety. improvements of sleep quality in pregnant women during treatment with b. pinnatum preparations were already shown in previous studies. this exploratory study aims at investigating the effects of b. pinnatum for the treatment of anxiety in patients with signs of preterm birth.

Eligibility criteria:
inclusion criteria: * at least 18 years old * hospitalisation with signs of preterm birth * gestational age at randomisation \>22 weeks (22+0) and \<35 weeks (34+6) * good german or english skills * written informed consent exclusion criteria: * early premature rupture of the membranes (pprom) * factors that make soon delivery likely (pre-eclampsia, suspect cardiotocography, clinical signs of an amniotic infection) * body temperature \>38°c * cervical opening or cervical length \< 5 mm * contraindication for b. pinnatum, lactose or wheat protein allergy * taking bryophyllum 50% chewable tablets or powder 48 h before study inclusion * taking psychotropic drugs (benzodiazepines, antidepressants, neuroleptics) * diagnosed psychiatric disease (depression, anxiety disorder, adaptation disorder, post- traumatic stress disorder, bipolar disorder) * active participation in another interventional study during the last 4 weeks * known or suspected non-compliance with study protocol * drug or alcohol abuse

Keywords: bryophyllum pinnatum anxiety preterm labor sleep quality phytotherapy
rssearch patient registry-long term study of use of srs/sbrt

Conditions: Neoplasms; Arteriovenous Malformation of Central Nervous System; Trigeminal Neuralgia

Summary: the rssearch® registry is an international multi-year database designed to track srs/sbrt (stereotactic radiosurgery/stereotactic body radiation therapy) utilization, treatment practices and outcomes to help determine, over time, the most effective use of these systems in management of patients with life threatening tumors and other diseases. (this study was formally called reckord and included the cyberknife only; the reckord study continues as a cyberknife subset of rssearch.)

the registry is designed to help srs/sbrt (stereotactic radiosurgery/stereotactic body radiation therapy) users to understand utilization of and key treatment outcomes for these treatment approaches. some of the objectives include: allow participants to record information about usage of srs/sbrt in everyday practice, including patient characteristics and disease information, treatment plans and outcomes provide participants with ready access to data for publication of their own experience and as a tool for establishing collaborations with other participating sites facilitate quality improvement efforts for individual treatment providers understand the effectiveness of different treatment plans for different types of lesions, diseases and treatments the registry tracks select outcomes for each condition treated by srs/sbrt (for example, psa for prostate cancer); the registry also provides individual participants the ability to add additional outcomes for each and any condition of specific interest to their institutions. the registry is hosted by vision tree, inc who is an independent vendor of electronic registries; they are responsible for hipaa compliance, including all security mechanisms. patients will be enrolled prospectively. some retrospective patient data is likely to be included in order to capture both short and longer term outcomes data.

Eligibility criteria:
inclusion criteria: * diagnosis of benign or malignant tumors or other conditions deemed treatable by stereotactic radiosurgery or stereotactic body radiotherapy * willingness to sign an informed consent document or verbally agree to participation exclusion criteria: * there are no specific exclusion criteria, but patients who are unwilling to sign the icd or who decline participation will not be included

Keywords: radiosurgery cyberknife benign tumors malignant tumors cranial tumors extracranial tumors lung liver pancreas prostate stereotactic radiosurgery stereotactic body radiotherapy
bilateral superficial cervical plexus block in thyroid/parathyroid surgery

Conditions: Benign Tumor of Thyroid; Hyperparathyroidism

Summary: to compare efficacy and safety between bilateral superficial cervical plexus block combined with intravenous sedation (ra group) and general anesthesia (ga group) for thyroid and parathyroid operations. this study evaluates postoperative numerical pain score and systemic opioid requirement within 24 hours.

according to literature review, there is limit information about efficacy and safety of thyroid and parathyroid operations under bilateral superficial cervical plexus block combined with intravenous sedation without general anesthesia. general anesthesia is commonly used for neck operations because it is easy to perform. however in high cardiovascular or pulmonary risk patients such as end stage renal disease (esrd) patients, regional anesthesia such as superficial cervical plexus block combined with intravenous sedation have become an alternative technique for neck operations. this study evaluate whether regional anesthesia (ra) technique can be the alternative technique for thyroid/parathyroid surgery compare to conventional technique (ga).

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) grade i-iii, aged over 18 years * elective thyroidectomy, thyroid lobectomy, parathyroidectomy exclusion criteria: * language barrier or inability to communicate with the operating team * allergy to local anaesthetic * known substernal, retroesophageal or retrotracheal goiter * thyroid cancer * previous neck exploration or neck radiation * recurrent laryngeal nerve paralysis * bmi ≥ 30

Keywords: bilateral superficial cervical plexus block thyroid surgery parathyroid surgery
the clinical results of derotational osteotomy based on 3d osteotomy template for treatment of recurrent patellar dislocation combined with patellofemoral maltracking

Conditions: Recurrent Patellar Dislocation; Osteotomy; Patellar Maltracking

Summary: for severe recurrent patellar dislocation with poor patellar maltracking, derotation osteotomy is an effective clinical treatment. however, derotation osteotomy requires very high requirements for the surgeon. it is necessary to determine the osteotomy surface, control the axis and complete internal fixation in three dimensions. the deviation of the osteotomy surface may cause deformities such as postoperative knee valgus, knee hyperextension, or restricted extension. the hypothesis of this study is to design a 3d osteotomy template for derotation osteotomy with the aid of computer-assisted simulated surgery. compared with traditional osteotomy, it can effectively improve the treatment effect of recurrent patellar dislocation due to poor patellar maltracking. the incidence of postoperative knee valgus shortens the operation time and reduces the number of intraoperative fluoroscopy. this study intends to adopt a randomized controlled study, and the selection criteria are adolescent patients with recurrent patellar dislocation, aged \>14 years, with a positive j sign. the experimental group used mimics 20.0 software to reconstruct the three-dimensional model of the patient based on the full-length images of the lower limbs in the weight-bearing position and the ct of the hip, knee and ankle before the operation. the osteotomy template was designed and 3d printing technology was used to make the osteotomy template for intraoperative osteotomy. the control group used traditional de-rotation techniques. the knee joint range of motion, patella stability, residual rate of j-sign, knee valgus angle, femoral anteversion angle, gait analysis, etc. were compared between the two groups after surgery, and the differences between the two surgical techniques were evaluated


Eligibility criteria:
inclusion criteria: * patients with recurrent patellar dislocation * \>14 years old * positive preoperative j-sign * agree to participate the study exclusion criteria: * combined with other ligament injuries of knee joint * skin and soft tissue conditions do not permit surgery
comparison of ultrasound-guided intraarticular hip injections with and without prior local anesthesia

Conditions: Hip Pain

Summary: in this single-center randomized controlled trial, subjects undergoing a first-time ultrasound-guided unilateral intraarticular hip injection will be randomized into one of two groups: hip injection with prior local anesthesia (with la) or hip injection without prior local anesthesia (without la). visual analog scale (vas) pain scores (0-100) will be collected after the local anesthesia injection (with la group) and intraarticular hip injection (both groups). the primary outcome measure for comparison between the two groups will be vas score for the intraarticular hip injection.


Eligibility criteria:
inclusion criteria: * patients undergoing a first-time ultrasound-guided unilateral intraarticular hip injection * subjects must be fluent in english * subject must be able to consent for themselves and mark pain levels on a visual analog scale. exclusion criteria: * previous intraarticular hip injection (to remove bias from prior injection experiences) * prior surgery on the hip to be injected * use of opioid medication on the day of or day before the procedure * diabetes mellitus * body mass index (bmi) greater than 40
economic outcomes of eqw (exenatide once weekly) vs. ig (insulin glargine) in t2d patients who are new to injectable therapy

Conditions: Diabetes Mellitus Type 2

Summary: primary objective of this study is to compare diabetes-related healthcare utilization and costs in patients initiating exenatide once weekly vs insulin glargine.

this retrospective, observational cohort analysis will assess medical and pharmacy claims for adult patients with type 2 diabetes from the truven health marketscan® commercial and medicare supplemental claims databases between 2011 and 2015. diabetes-related healthcare utilization and costs will be measured as a primary outcome. secondary outcomes include all-cause healthcare utilization and costs, major adverse cardiovascular event (mace)-related utilization and costs, and medically attended hypoglycemia events.

Eligibility criteria:
inclusion criteria: 1. one or more outpatient prescription claim for eqw (exenatide once weekly) vs. ig (insulin glargine) between february 1, 2012, and june 30, 2014 (date of first claim = index date; medication to which first claim corresponds = index therapy). 2. aged 18 or older as of the index date. 3. continuous enrollment in medical and pharmacy benefits for 12 months before (baseline period) and 12 months after (follow-up period) the index date. (6 months follow-up will be provided to determine the effect on sample size.) 4. one or more medical claims with a diagnosis code for t2dm (icd-9-cm 250.x0 or 250.x2) in the baseline period or on the index date. exclusion criteria: 1. no outpatient prescription claims for any injectable glucose-lowering medication during the baseline period (glp-1ra or insulins). 2. no medical claims with a diagnosis (or procedure, where appropriate) code indicative for type 1 diabetes mellitus (icd-9-cm 250.x1 or 250.x3), gestational diabetes (icd-9-cm 648.8x), or pregnancy or childbirth in the baseline or follow-up periods.

Keywords: diabetes mellitus type 2
a study of nivolumab plus brentuximab vedotin versus brentuximab vedotin alone in patients with advanced stage classical hodgkin lymphoma, who are relapsed/ refractory or who are not eligible for autologous stem cell transplant,

Conditions: Hodgkin's Disease

Summary: the purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with brentuximab vedotin compared to brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory classical hodgkin lymphoma. the participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant


Eligibility criteria:
inclusion criteria * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. * participants must have a pathologic diagnosis of classical hodgkin lymphoma (chl) who are relapsed or refractory with one of the following:. i) autologous stem cell transplant (asct) ineligible patients. ii) patients after failure of asct. - must have at least one lesion that is \> 15 mm (1.5 cm) in the longest diameter and avid by fluoro deoxy glucose (fdg) positron emission tomography (pet) scan. exclusion criteria * known central nervous system lymphoma. * participants with nodular lymphocyte-predominant hodgkin lymphoma (hl). * participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (pml). * other protocol-defined inclusion/exclusion criteria apply.
evaluation of personalised support program effectiveness in sperm quality improvement

Conditions: Male Infertility

Summary: fablife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan france. the main objective is to evaluate the effect of fablife personalised program over a period of 15 weeks on the improvement of spermatic dna fragmentation in subfertile men compared to general dietary recommendations.

more than 15 % of couples couldn't get pregnant after at least a year of unprotected intercourse. the fablife personalised program aims to improve sperm quality including sperm dna fragmentation in subfertile men through: * a personalized dietary program based on patient's phenotype and genotype * a daily dietary supplement, developed in the context of male infertility a total of 75 patients will be recruited: * 46 patients will benefit from the program, * 23 patients will form the control group. * 6 patients will not answer to all the criteria.

Eligibility criteria:
inclusion criteria: * all male volunteers aged 18 to 45 years belonging to a couple reporting an involuntary infertility greater than 12 months * conventional spermatic parameters compatible with spontaneous pregnancy * sperm count\> 5m / ml and * progressive sperm mobility\> 20% * negative spermoculture * fragmentation of sperm dna\> 20% * patient able to understand dietary recommendations given in french, in writing and orally * social insured patient receiving benefits from the french social security health branch * patient with a mobile phone (ios or android) with internet access exclusion criteria: * patient diagnosed with severe oligospermia (\<5 million spz / ejaculate) * patient with bmi\> 35 or \<18.5 * patient with known and treated diabetes * patient with known and treated lipid disorders * patient with known and treated cardiovascular diseases * patients with known and treated hypertension * patients with known and treated dysthyroidism * patients with known symptomatic varicocele * patient with known inflammatory bowel diseases * patient with renal failure diagnosed * patient presenting a viral risk (hiv / hepatitis b and c / ...) requiring support in a dedicated circuit * patient unable to give informed consent * minors and protected adults, vulnerable people * patient participating in another clinical research study
evaluation of circulating neutrophils in antisynthetase syndrome

Conditions: Antisynthetase Syndrome

Summary: antisynthetase syndrome (asys) is a rare and heteregeneous overlapping connective tissue disease, characterized by myositis, interstitial lung disease (ild), joint involvement, raynaud's phenomenon and cutaneous manifestations ("mechanic's hands"). over 50% of patients develop ild, which is the leading cause of death. the role of neutrophils - innate immune cells involved in inflammatory processes and induced in particular by cytokines of the th17 pathway - during as is unknown. direct pathogenic role of neutrophils has been described during idiopathic inflammatory myopathies, with an increase of netosis correlated with disease activity and muscle damage. during asys, a higher number of alveolar neutrophils has been observed in patients with rapidly progressive ild. there are few data on the specific evaluation of circulating neutrophils in asys. investigators suppose that circulating neutrophils level could represent a simple and accessible severity biomarker in patients with asys. the main objective is to evaluate the diagnostic performance of the circulating neutrophils level (\> 7000/mm3) at diagnosis on asys severity. the secondary objectives are: * to define a threshold for circulating neutrophils levels at diagnosis allowing to predict asys severity and to assess the diagnostic performance of this threshold. * to study the correlation between the level of circulating neutrophils and asys severity at diagnosis of the disease. * to compare the circulating neutrophils level at asys diagnosis and after 1 year of treatment. * to compare patients characteristics according to asys severity at diagnosis. * to compare bal fluid neutrophils level according to ild severity at asys diagnosis in patients with ild.


Eligibility criteria:
inclusion criteria: * patients with asys diagnosis according to connors criteria exclusion criteria: * active infection at asys diagnosis * evolutive cancer at asys diagnosis * corticosteroid therapy initiation before circulating neutrophils evaluation
national longitudinal cohort of hematological diseases

Conditions: Multiple Myeloma; Myeloma, Multiple; Myelomas, Multiple; Acute Myeloid Leukemia; Leukemias, Acute Myeloid; Myeloid Leukemias, Acute; Hemophilia; Hemophilia A; Hemophilia As; Hemophilia B; Hemophilia Bs; Myelodysplastic Syndrome; MDS; Lymphoma; Leukemia; Aplastic Anemia; Bleeding Disorder; Bone Marrow Transplantation; Blood Disease Infection

Summary: background hematological diseases are disorders of the blood and hematopoietic organs. the current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in china. there is a lack of comprehensive and large-scale prospective cohort studies in hematology. the purpose of this study is to analyze the incidence and risk factors of major blood diseases, the treatment methods, prognosis and medical expenses of these patients in china. method the study will include patients diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders, blood infection or received bone marrow transplantation in the investigating hospitals from january 1, 2020, and collect basic information, diagnostic and treatment information, prognosis information, as well as medical expense information from medical records. in its current form, the niche registry incorporates historical data (collected from 2000) and is systematically collecting prospective data in two phases with broadening reach, and prospectively follow-up to collect the prognosis information.


Eligibility criteria:
inclusion criteria: * patients who were diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders or received bone marrow transplantation in the investigating hospitals from january 1, 2020. exclusion criteria: * long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease. * alcohol and drug addictions affect their ability to comply with study requirements. * according to the investigator, there are conditions that may endanger the patient's safety or affect his/her compliance.
medical marijuana use in hiv+ patients prospective cohort study

Conditions: HIV Positive; Marijuana Smoking

Summary: the investigators are interested in understanding personal factors such as medical conditions and mental health, as well as social and economic factors, that influence marijuana (and other substance) use in hiv-positive patients. several alternative hypotheses will be evaluated in the proposed project: 1. healthier patients may self-select marijuana use; 2. marijuana use may be associated with consequences that create barriers to seeking healthcare; 3. marijuana use may have medicinal value that reduces the need for such care.

the study will involve a total of 5 interviews with clinical research staff members, the total involvement will be for about 1 year. the first interview will establish a baseline of current behaviors and health status; this will take about 3-4 hours. this interview will take place at the tolan park medical building, located at 3901 chrysler service dr. the remaining 4 interviews - which will be shorter in length - will be conducted about 3, 6, 9, and 12 months after the baseline interview; each follow-up interview will take about 2 hours.the purpose of the 4 remaining interviews is to assess changes in behaviors and health status over time. we will collect urine samples at each of the 5 interview sessions to assess health and illicit drug use.

Eligibility criteria:
inclusion criteria: * participants will be patients in the hiv clinic. * participants will have hiv. * participants will sign a single consent form. * participants will be marijuana users. exclusion criteria: * participants who test negative for marijuana will be excluded. * volunteers who exhibit signs of drug intoxication or cognitive/mental impairment during the consent process will be excluded.

Keywords: hiv positive medical marijuana